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Regeneron's Rilonacept Granted European Marketing Authorization for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Date:10/27/2009

. In the pivotal clinical development program, patients treated with rilonacept reported a greater improvement in overall symptom scores than patients treated with placebo. These improvements were sustained over time with continued rilonacept treatment. Patients reported their symptoms using a validated daily diary instrument. These assessments represent a critical measure of effectiveness in a disease characterized by frequent, unpredictable symptom flares of variable severity and duration. Unlike other agents used in the treatment of CAPS, rilonacept is supported by patient-reported symptoms data using a validated assessment instrument.

Rilonacept has been developed as a once-weekly injection which can be administered at home by the patient or their care giver following appropriate training. The most commonly reported adverse reactions with rilonacept were injection-site reaction and upper respiratory tract infection. IL-1 blockade may interfere with immune response to infections and treatment should not be initiated in patients with active or chronic infections. There have been reports of serious, life-threatening infections in patients taking rilonacept. Rilonacept should be discontinued if a patient develops a serious infection.

The authorization for approval of rilonacept in the E.U. under exceptional circumstances is permissible for products for which a company can demonstrate that comprehensive data cannot be provided, for example because of the rarity of the condition. Each year, Regeneron will need to provide the EMEA with any new information that may become available for review.

About Cryopyrin-Associated Periodic Syndromes (CAPS)

Recently, medical researchers have identified and described a group of rare, inherited, auto-inflammatory disorders, known as Cryopyrin-Associated Periodic Syndromes or CAPS. Three related conditions make up the broader disease known as CAPS: Familial Cold Aut
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SOURCE Regeneron Pharmaceuticals, Inc.
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